Psilocybin Therapy for MeUD and HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 trial, adults with HIV and methamphetamine use disorder are randomly assigned to receive either 25 mg or 5 mg of psilocybin in a monitored session, along with three preparation and three integration therapy visits. Participants will report methamphetamine use before, during, and up to three months after the dosing session, and may be eligible for one additional open-label 25 mg session after four weeks. The study aims to determine feasibility, acceptability, safety, and tolerability of this approach in the target population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 25 to 64
* Diagnosed with HIV at least 3 months ago
* Moderate-to-severe methamphetamine use disorder
* Uses methamphetamine regularly and identifies it as their primary drug
* Has a goal of quitting methamphetamine use
* Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions
* Currently living indoors with stable housing anticipated for the duration of the study
* Has a text-capable cellphone
* Willing to use highly effective contraception and not donate sperm throughout the study
* Able to participate in study procedures in English

Exclusion Criteria:

* History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment
* Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)
* Currently taking certain medications that may interact with psilocybin
* Recent use of a psychedelic drug
* Certain significant heart, liver, or kidney conditions
* Uncontrolled high blood presure (i.e., \>150/90 mmHg)
* History of stroke or seizure in the past year
* Current pregnancy or breastfeeding
* Current involvement in the criminal legal system that would be expected to interfere with study participation
* Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month

Note: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.

Where it's running

• UCSF at Zuckerberg San Francisco General Hospital
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Nicky J. Mehtani, MD, MPH — University of California, San Francisco
• Study coordinator: Eliza Banbury, BA
• Email: prism.trial@ucsf.edu
• Phone: 510-985-3522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.